Phase 4
N=260
Sugammadex vs Placebo to Prevent Residual Neuromuscular Block
General Surgery
Bottom Line
View on ClinicalTrials.gov: NCT02728726 ↗Enrolled (actual)
260
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Decreased Minute Ventilation (MV) — 20; 26 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Sugammadex (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mayo Clinic
- Primary completion
- Dec 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Decreased Minute Ventilation (MV) |
20; 26 | — |
| PRIMARY Decreased Average Minute Ventilation (MV) |
20; 26 | — |
| SECONDARY Train of Four (TOF) Ratio |
42; 29 | — |
Summary
The study is designed to determine whether patients who receive sugammadex immediately after tracheal extubation will exhibit a decrease in the incidence of postoperative residual paralysis and an associated decrease in the incidence of postoperative respiratory depression.
Eligibility Criteria
Inclusion Criteria
- Patients undergoing surgery with general anesthesia
- Patients weighing > or = 80 pounds
- Patients not intubated prior to surgery
- Patients who are able to give informed consent
Exclusion Criteria
- Patients unable to give informed consent.
- Patients whose condition will not allow for placement of the electrode PadSet of ExSpiron
- Patients who are anticipated to remain intubated in recovery period.
Data sourced from ClinicalTrials.gov (NCT02728726). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.